Are you interested in giving your views on new medicines and medical devices?
How to get involved in the EU Health Technology Assessment – for patients, carers and clinicians
Patients, carers and clinical experts are involved in the joint HTA work as individual experts contributing to joint clinical assessments and joint scientific consultations.
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What roles can you play?
Overview of the selection and involvement process
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Express interest
If you are interested in participating in the joint work on clinical assessments and scientific consultations, get in touch with a national or EU-level patient or clinician organisation. They will receive requests from the European Commission for individual experts and may be able to nominate you. You can also reach out to your national HTA authority or body, who also receive our requests for identifying experts.
Frequently asked questions
Which medicinal products does the joint work cover?
The EU HTA Regulation takes a staggered approach to all medicinal products seeking centralised marketing authorisations.
From 12 January 2025 onwards, a marketing authorisation application for a new cancer medicine or advanced therapy medicinal product validated by the European Medicines Agency will trigger a joint clinical assessment.
Selected high-risk medical devices will also undergo joint clinical assessment from 2026 onwards. The rules will be extended to orphan medicinal products in January 2028, and cover all new medicinal products by 2030.
How are patients and clinicians selected?
To identify patients, carers and clinical experts, the Health Technology Assessment (HTA) Secretariat can consult the sources listed in the relevant implementing regulations. These include:
- HTA stakeholder network members
- European Reference Networks (ERN) for rare and complex diseases and their respective European patient advocacy groups
- Orphanet, the portal for rare diseases and orphan drugs
- National contact points for clinical trials
If the first round of requests does not result in enough individual experts to be identified, the HTA secretariat may consult other existing databases or directories, or contact members of the HTA Member State Coordination Group, its subgroups and relevant European Union and international agencies and organisations.
What happens after I am nominated?
Once the organisation who nominated you has sent your contact details to the HTA Secretariat, we will send you an email explaining the process which consists of:
Completion of the Declaration of Interest (DOI) form and submission of your CV
- An invitation will be sent to complete the DOI and to submit a CV on the HTA IT Platform. You will have to create an EU login to access the HTA IT Platform. with an EU login account.
Conflict of interest assessment and list of suitable experts
- The HTA Secretariat will assess your DOI in accordance with Regulation 2024/2745. Annex II sets out what may constitute a conflict of interest.
- Based on the assessment, the HTA Secretariat will prepare a list of eligible patients, carers and clinical experts for the relevant Joint Clinical Assessment or Joint Scientific Consultation Subgroup.
- Selection by the relevant subgroup
- The relevant subgroup will select experts from the list of eligible patients, carers and clinical experts prepared by the HTA Secretariat for each specific Joint Clinical Assessment or Scientific consultation. Please note that being proposed as an expert by the HTA Secretariat does not necessarily mean that you will be selected by the subgroup.
- If not selected:
The HTA Secretariat will inform all experts who are not selected. Not being selected for a specific procedure does not mean that you will not be able to participate in others. The HTA Secretariat will retain contact details, DOI and CV of all experts for up to three years, after which it will be deleted.
During this time, if your expertise is required for any future joint clinical assessments or scientific consultations, we may contact you requesting an updated DOI and CV.
- If selected: Next steps
- If you are selected, your contact details will be transferred to the Brussels Centre for Collaboration in Health which provides administrative support to the assessor and co-assessor for each Joint Clinical Assessment or Joint Scientific Consultation case. .
- The administrative team will contact you to sign confidentiality agreements and complete paperwork for compensation. They will also provide you with further guidance.
How many individual experts are selected per procedure?
The HTA Secretariat compiles a list of available patients and clinical experts. The number of experts compiled for a specific case varies depending on the consultation results with the sources listed above to identify individual experts. The Joint Clinical Assessment or Joint Scientific Consultation Subgroup then has the discretion to select experts.
Selection criteria
- To be eligible, you must submit:
- Declaration of Interest (DOI)
- detailed CV based on the Europass CV template.
- Selection by the Joint Clinical Assessment or Joint Scientific Consultation subgroup is based on:
- relevance of your expertise to the therapeutic area
- geographical scope — ideally covering multiple Member States
compliance with conflict-of-interest rules
Note: Not being selected for one procedure does not exclude you from others. Your details will be kept on file for up to three years for future opportunities.
Is a scientific background in medicine or health economics necessary?
Patients and carers make a unique and valuable contribution based on their experience of the disease and its current treatment options. They are not expected to be knowledgeable about health technology assessment methods as such. They are valued for sharing their experiences of the health condition, such as navigating its various stages, reflecting on past treatment outcomes and expressing their needs for the new therapies. For instance, they can offer insights into whether comparators identified by the subgroup align with patients' needs and preferences.
Clinicians contribute with their expertise and experience from day-to-day clinical practice, including prescribing, dispensing and administration of medicines and medical devices. Clinical experts will share their knowledge about important factors in patient treatment and what therapies can or cannot currently do.
How were the conflict-of-interest rules decided?
The conflict-of-interest rules were adopted following extensive discussions with EU Member States and considering stakeholder feedback. These rules are essential for maintaining the highest standards of independence, impartiality and transparency in joint work.
They ensure appropriate access to relevant expertise, with different measures applying depending on the declared interests, roles and responsibilities of experts. In exceptional cases, such as for rare diseases, experts could be involved in the joint work despite their conflicts of interest. [insert link to one-pager on COI]
Is participation in joint HTA work paid?
The European Commission has signed a framework contract with a consortium of HTA bodies currently representing different EU countries to fund joint clinical assessments and joint scientific consultations.
Through the framework contract, individual experts participating in joint clinical assessments and joint scientific consultations are entitled to a compensation in line with the Commission’s general rules for compensation of experts (Commission Decision C(2014)2220 – special allowance to participants in the activities of a Commission expert group, as provided for in the horizontal rules for Commission expert groups (C(2016)3301)). They will get EUR 450 for a full day and EUR 225 for half a day.
In what language will the communication and activities be?
All communication and consultations are in English. Unfortunately, there is currently no option to have communications translated into another language or have an interpreter present during meetings.
Is there any support provided to patients and their carers to take part in the joint work under the EU HTA Regulation?
Under the EU4Health programme, the Commission co-funded two capacity-building projects focused on training patients and patient organisations with the necessary knowledge to enable meaningful involvement in the HTA joint work.
These projects are HTA4Patients and European Capacity Building for Patients. They have developed informative materials on health technology assessment and the EU HTA Regulation.
In addition, throughout the process, the HTA Secretariat is available to answer any questions, and the IT team is available to provide IT support in case of issues accessing the HTA IT Platform.
Once you are selected, the Brussels Centre for Collaboration in Health team, who will provide administrative support, will assist you throughout the process, including signing confidentiality agreements and completing paperwork for compensation and data protection.
Role of patients and clinicians in joint clinical assessment
Joint Clinical Assessment
- Scoping Phase
Review the draft assessment scope developed by Member States. The assessment scope defines the key research questions according to four parameters, commonly known as PICO:
- Population (who is affected)
- Intervention (the treatment being assessed)
- Comparison (other treatments, the intervention should be compared to)
- Outcome (expected results).
An example of a research question is: “In adults with hypertension (P), is the use of a new antihypertensive medicine (I) more effective than a standard medicine (C) at reducing blood pressure (O)?”.
The final assessment scope is then sent to the health technology developer (company) who must provide clinical evidence to answer the research questions (dossier).
Share your input in writing (7-day window).
- If requested , join a subgroup meeting to provide input.
- Assessment Phase
- Respond to questions by the assessor and co-assessor, and share your input in writing during the preparation of the draft report and summary report, if needed.
- Review the draft report and summary report developed by the Subgroup (7-day window).
If requested, join a subgroup meeting to provide input.
What is the role of patients and clinicians in Joint Scientific Consultations?
Joint Scientific Consultations
- Review the information sent by the health technology developer (company). This documentation is called the briefing package and is a document where the developer explains how they intend to proceed with their data development and ask questions to the assessors whether the data development plan is expected to meet requirements of the Member States.
- Share your input via questionnaire or interview.
Join a virtual meeting with the health technology developers, the assessors, the JSC Subgroup and EU experts. In this meeting, the data development plans will be discussed, and the experts might provide their views directly to the health technology developers.
Your input ensures that patients’ needs and clinical practice realities are reflected.
Which personal information must be provided?
To be considered for the selection process, you need to submit a Declaration of Interest along with a detailed CV (resume). The following personal information needs to be collected:
- name
- email address
- phone number
- country of residence
- CV (resume)
- skills and experience
- place of practice (if applicable)
details included in the declarations of interests
(For patients: information about your health condition related to the specific JCA or JSC. Only the data necessary to ensure participation in line with EU legislation will be collected.
How will your personal data be protected?
All personal data in electronic format (e-mails, documents, databases, uploaded batches of data and more.) are stored either on servers belonging to the European Commission or by its contractors. All processing operations are carried out according to Commission Decision 2017/46 – security of communication and information systems in the European Commission.
The Commission’s contractors are bound by:
- a specific contractual clause governing all processing operations of your data on behalf of the Commission
confidentiality obligations deriving from the transposition in EU member states of Regulation 2016/679 – protection of natural persons with regard to processing of personal data and free movement of such data
To ensure your data is safe, the Commission applies a combination of technical and organisational safeguards:
- Technical measures protect against data loss, unauthorised access and cyber threats, according to the sensitivity of the data.
- Organisational measures ensure that only authorised staff with a legitimate need have access to personal information. Only clinicians’ names will be published on the Joint Clinical Assessment, along with their Declarations of Interest on the Europa website. The names of patients and their Declarations of Interest will not be made publicly available. In case of virtual meetings (no meetings in person are foreseen) for example with the health technology developer during the Joint Scientific Consultations, patients do not have to disclose their identity.
